Volume 27, Issue 6 , Pages 428-429, July 2004
Informed Consent: A Potential Dilemma for Complementary Medicine
Article Outline
Introduction
In January 2003, the United Kingdom General Medical Council temporarily dismissed a general practitioner from the medical register who had treated patients with various forms of complementary medicine (CM).1 The main reason for this action was that she had not obtained informed consent from her patients to use CM. The necessity for informed consent arises out of our respect for patient autonomy and is an essential prerequisite in all clinical medicine.2 In this brief article, I will discuss the issue of informed consent in CM using the example of chiropractic treatment. Chiropractic was chosen because chiropractors are one of the largest groups of CM practitioners, because the problem of informed consent is more thoroughly acknowledged by chiropractors than by other CM practitioners,3 and because there is more clinical evidence in chiropractic than in many other areas of CM. My aim is to stimulate discussion about informed consent in the clinical practice of CM with a view toward finding solutions to the emerging problems. The onus to obtain informed consent is legal as well as ethical.3 My discussion will be mostly on the latter aspect.
The Code of Practice of the British General Chiropractic Council (GCC) states that, “Before instituting any examination or treatment, a chiropractor shall ensure that informed consent to such treatment or examination has been given. Failure to obtain informed consent may lead to criminal or civil proceedings…Informed consent means consent that is given by a person who has been supplied with all the necessary relevant information.”4 The United Kingdom Department of Health agrees with the GCC: “Before you examine, treat or care for competent adult patients you must obtain their consent.”5 In the chiropractic literature, the necessity of informed consent has been repeatedly acknowledged: “where there is a risk of significant harm from the treatment proposed, this risk must be disclosed, understood and accepted by the patient.”6 The clear message is that clinicians require consent from all patients after they have been “supplied with all the necessary relevant information.”4 Consent can be given orally or in writing, but a record about what information was given and whether it was understood is desirable, particularly when material risks are involved.3 Patients voluntarily seeking chiropractic treatment can be seen as giving “implied consent,”3 but “the best record of consent is one that is objectively documented (eg, a witnessed written consent or videotape).”6
A crucial question follows: what information should be considered “necessary and relevant”4 for obtaining informed consent? Courts and legislators in the United States have differed as to the appropriate standard of disclosure.3 Appropriate may either be judged as what the “reasonable” practitioner or the “reasonable” patient thinks is appropriate. The latter, it has been argued, is more applicable to holistic health practices such as chiropractic, but the former seems to be current practice.3 The United Kingdom Department of Health states that “patients need sufficient information…, for example, information about the benefits and risks of the proposed treatment and alternative treatments.”5 But what exactly does this mean? What is “sufficient information”5 and what is “significant harm?”6
Consider a patient consulting a chiropractor because of her chronic neck pain.2 The United Kingdom and United States guidelines clearly want the chiropractor to explain (1) the diagnosis, (2) the benefits of the chiropractic approach for neck pain, (3) its risks, and (4) the risks/benefits of other therapeutic options.2., 3., 5.
Selected pieces of evidence are unlikely to provide conclusive information regarding benefit. Only the totality of the trial data will give the full picture. The most up-to-date systematic review of chiropractic spinal manipulation for neck pain included 4 randomized clinical trials (RCTs) and concluded that “the notion that chiropractic spinal manipulation is more effective than conventional exercise therapy in the treatment of neck pain is not supported by rigorous trial data.”7 Others come to more positive conclusions, but undoubtedly there is a degree of uncertainty. According to the above guidance, chiropractors should convey this message to their patients consulting for neck pain.2
And what about the risks? Spinal manipulation is associated with mild, transient adverse effects in about 50% of all patients.8 Cervical manipulation is also burdened with serious complications, such as vertebral arterial dissections. Most chiropractors believe that such events are extreme rarities.9 However, underreporting can be close to 100%, a fact that renders estimates of incidence figures unreliable.10 Many chiropractors would find this view too negative, yet it is based on evidence and therefore requires, at the very minimum, some consideration. Chiropractors also concede that “cervical adjustment may be a contributing factor in rare patients with underlying disorders currently incapable of diagnosis… that means that clinicians using manual methods of treatment have a duty to disclose the risk.”6 Other treatments that have shown promise in the treatment of neck pain include exercise therapy, which is virtually free of serious adverse events or complications.11 Again, the above guidance would require chiropractors to convey these messages to their patients.
The dilemma that emerges seems clear: informed consent compels chiropractors to tell neck pain patients firstly that the benefit of chiropractic spinal manipulation is uncertain, secondly that its risks are not negligible, and thirdly that other therapeutic options are not associated with harm. Such information is likely to deter patients from choosing chiropractic treatment. Thus, informed consent can work against the financial interests of CM practitioners, most of who are privately paid by their patients.
My point is that in CM, rigorously applied informed consent has the potential to create serious conflicts of interest. These are problems that are likely to emerge in many areas of CM and could “lead to liability for damages in negligence if such a risk materialises.”3 This danger is increased as “the trends in the courts, hospital guidelines and the advice from professional ethicists all point towards more comprehensive disclosure of risks involved in treatments.”12 I do not see an easy solution to the emerging problems. But I feel that we need to discuss them, think them through thoroughly, and work toward finding solutions.
References
- . Three-month ban for homeopathy GP. Available at: http://news.bbc.co.uk/1/hi/england/2666411.stm Accessed June 6, 2003
- . Informed consent in complementary and alternative medicine. Arch Intern Med. 2001;161:2288–2292
- . Informed consent to chiropractic treatment. In: Lawrence DJ, Cassidy JD, McGregor M, Meeker WC, Vernont HT editor. Advances in chiropractic. Vol 1:Chicago: Mosby-Year Book, Inc; 1994;p. 193–218
- Code of practice. London: General Chiropractic Council; 1999. p. 3.
- . In: The handbook of clinical trials and other research. Oxford: Radcliffe Medical Press; 2002;p. 81–82
- . Manipulation as safe as normal neck movements. Chiropr Rep. 2003;17:1–8
- . Chiropractic spinal manipulation for neck pain: a systematic review. J Pain. 2003;4:417–421
- . Prospective investigations into the safety of spinal manipulation. J Pain Symptom Manage. 2001;21:238–242
- . Chiropractic. Prim Care Clin Office Pract. 2002;29:419–437
- . Neurological complications of cervical spine manipulation. J R Soc Med. 2001;94:107–110
- A critical appraisal of review articles on the effectiveness of conservative treatment for neck pain. Spine. 2001;26:196–205
- . Informed consent. J Ir Coll Physicians Surg. 2002;31:219–221
PII: S0161-4754(04)00105-8
doi:10.1016/j.jmpt.2004.05.010
© 2004 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.
Volume 27, Issue 6 , Pages 428-429, July 2004
